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Health and Human Services Department

468 documents across 48 days of the archive, 37 of them final rules. The five most recent days are below.

Dates this agency has set that have not yet arrived

What is in this list

Comment deadlines and effective dates from anything this agency published in the archive, still ahead of 19 October 2026.

Dates set before this archive began are not here, and their absence is not evidence that none exist.

as_of

  1. today Comments close Determining Whether To Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; Availability Health and Human Services Department · Food and Drug Administration
  2. today Comments close Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Voluntary Partner Survey on HRSA Customer Service, OMB No. 0906-0084-Revision Health and Human Services Department · Health Resources and Services Administration
  3. today Comments close Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Rural Maternity and Obstetrics Management Strategies Program Data Collection, OMB No. 0915-0394-Revision Health and Human Services Department · Health Resources and Services Administration
  4. today Comments close Proposed Data Collection Submitted for Public Comment and Recommendations Health and Human Services Department · Centers for Disease Control and Prevention
  5. today Comments close Proposed Data Collection Submitted for Public Comment and Recommendations Health and Human Services Department · Centers for Disease Control and Prevention
  6. today Comments close Draft NIH Biosafety Policy for Research Involving Biohazards Health and Human Services Department · National Institutes of Health
  7. +1d Comments close Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Faculty Loan Repayment Program, OMB No. 0906-0082-Revision Health and Human Services Department · Health Resources and Services Administration
  8. +1d Comments close Agency Information Collection Activities: Proposed Collection; Comment Request Health and Human Services Department · Centers for Medicare & Medicaid Services
  9. +1d Comments close Agency Information Collection Activities: Proposed Collection; Comment Request Health and Human Services Department · Centers for Medicare & Medicaid Services
  10. +2d Comments close Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs Health and Human Services Department · Food and Drug Administration
  11. +2d Comments close Request for Information on Electromagnetic Fields (EMFs), Radiofrequency (RF) Radiation, and Wireless Radiation Exposure Health and Human Services Department
  12. +3d Comments close Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Questionnaire and Data Collection Testing, Evaluation, and Research for the Health Resources and Services Administration, OMB No. 0915-0379-Revision Health and Human Services Department · Health Resources and Services Administration
  13. +3d Comments close Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Generic Information Collection Request for Health Resources and Services Administration Hotlines, Chatlines, and Online Portals Health and Human Services Department · Health Resources and Services Administration
  14. +3d Takes effect Submission for OMB review; 30-Day Comment Request; the Impact and Costs of Promoting Objectivity in Research 42 CFR Part 50 Subpart F and Responsible Prospective Contractors 45 CFR Part 94 (Office of the Director) Health and Human Services Department · National Institutes of Health
  15. +4d Comments close Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability Health and Human Services Department · Food and Drug Administration
  16. +4d Comments close 2025-2026 IACC Summary of Advances Health and Human Services Department · National Institutes of Health
  17. +7d Takes effect Request for Information (RFI): Request for Information on New and Emerging Areas of Science Relevant to the NIDCD Mission, To Inform an Update of the NIDCD Strategic Plan for 2028-2032 Health and Human Services Department · National Institutes of Health
  18. +7d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health Health and Human Services Department · Food and Drug Administration
  19. +7d Comments close Agency Information Collection Activities: Proposed Collection; Comment Request Health and Human Services Department · Centers for Medicare & Medicaid Services
  20. +7d Comments close Draft NIH Policy on Sharing Summary Level Study Results With Clinical Research Participants Health and Human Services Department · National Institutes of Health
  21. +7d Comments close Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 Inactive Bakers Yeast Health and Human Services Department · Food and Drug Administration
  22. +7d Comments close Privacy Act of 1974; Matching Program Health and Human Services Department · Centers for Medicare & Medicaid Services
  23. +7d Comments close Prospective Grant of Exclusive License, Inter-Institutional Agreement-Institution Lead: Antibody Specifically Binding to Severe Fever With Thrombocytopenia Syndrome Virus Antigen and Use Thereof Health and Human Services Department · National Institutes of Health
  24. +8d Comments close Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: The National Health Service Corps Loan Repayment Programs OMB No. 0915-0127-Revision Health and Human Services Department · Health Resources and Services Administration
  25. +8d Comments close Proposed Data Collection Submitted for Public Comment and Recommendations Health and Human Services Department · Centers for Disease Control and Prevention
  26. +8d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Qualitative Feedback on Agency Service Delivery Health and Human Services Department · Food and Drug Administration
  27. +8d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers Health and Human Services Department · Food and Drug Administration
  28. +8d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups and Interviews as Used by the Food and Drug Administration Health and Human Services Department · Food and Drug Administration
  29. +9d Takes effect Submission for OMB Review; 30-Day Comment Request; Health and Human Services Department · National Institutes of Health
  30. +9d Takes effect Submission for OMB Review; 30-Day Comment Request; Generic Clearance for NIH Citizen Science and Crowdsourcing Projects (Office of the Director) Health and Human Services Department · National Institutes of Health

95 more beyond these.

16 October 2026 13 documents

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The Department of Health and Human Services published thirteen notices on October 16, 2026, including meeting announcements and information collection requests.

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NoticeHealth and Human Services DepartmentFood and Drug Administration

Electronic Common Technical Document (eCTD); Data Standards; Supporting Forward Compatibility for eCTD 4.0

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research are announcing support for Forward Compatibility for Electronic Common Technical Document (eCTD) Version 4.0 (v4.0)-based electronic submissions.

91 FR 65752FR Doc. 2026-21197official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Electronic Common Technical Document; Data Standards; Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Supporting Electronic Common Technical Document Version 3.2.2 and Version 4.0

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research are announcing the date FDA will begin rejecting electronic submissions that fail new Electronic Common Technical Document (eCTD) Version 3.22 (v3.22) and Version 4.0 (v4.0) based validations. The new eCTD v3.2.2 validations are 2024 and 2025, which are high-severity validation errors as described in the Specifications for eCTD Validation Criteria. The new eCTD v4.0 validations are eCTD4-084, eCTD4-085, US-eCTD4-561, US-eCTD4-562, US-eCTD4-563, and US-eCTD4-564, which are high-severity validation errors as described in the Specifications for eCTD v4.0 Validation Criteria.

91 FR 65749FR Doc. 2026-21195official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentChildren and Families Administration

Submission for Office of Management and Budget Review; Unaccompanied Refugee Minors Program ORR-3 Report and ORR-4 Report

The Office of Refugee Resettlement (ORR) is requesting a three-year extension with revisions of the Unaccompanied Refugee Minors (URM) Program ORR-3 Report and ORR-4 Report (Office of Management and Budget #0970-0034, expiration 11/30/2026). Revisions were made to reduce burden and streamline information collection.

  • Comments close in 28 days

91 FR 65748FR Doc. 2026-21186official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentCenters for Medicare & Medicaid Services

Agency Information Collection Activities: Proposed Collection; Comment Request

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

  • Comments close in 57 days

91 FR 65747FR Doc. 2026-21151official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentCenters for Medicare & Medicaid Services

Agency Information Collection Activities: Proposed Collection; Comment Request

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

  • Comments close in 57 days

91 FR 65746FR Doc. 2026-21150official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Fit-for-Purpose Rare Disease Framework Initiative; Public Meeting; Request for Information and Comments

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled "Fit-for-Purpose Rare Disease Framework Initiative". Convened by the Reagan-Udall Foundation for, and in collaboration with FDA, the meeting will focus on developing a fit-for-purpose framework for the development and regulatory review of rare disease therapies. There will be an opportunity to request to provide public comments at the meeting. In addition, FDA is establishing a public docket to collect feedback on and input related to its Rare Disease Framework Initiative.

  • Comments close in 53 days

91 FR 65750FR Doc. 2026-21142official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentCenters for Disease Control and Prevention

Meeting of the Advisory Council for the Elimination of Tuberculosis

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Council for the Elimination of Tuberculosis (ACET). This meeting is open to the public, limited only by the number of audio and web conference lines (1,000 lines are available). Time will be available for public comment (registration is required to provide oral comment; see the Oral Public Comment section below).

91 FR 65745FR Doc. 2026-21125official PDFfederalregister.gov

15 October 2026 6 documents

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The Health and Human Services Department published six notices on October 15, 2026, including emergency use authorizations for four animal drugs to prevent and treat New World screwworm infestations.

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NoticeHealth and Human Services DepartmentFood and Drug Administration

Authorization of Emergency Use for Four Animal Drugs for the Prevention and Treatment of New World Screwworm; Availability

The Food and Drug Administration (FDA or the Agency) is announcing the issuance of four Emergency Use Authorizations (EUA or Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for new animal products. FDA has issued one EUA for an animal product as requested by Elanco US Inc. for application on or around wounds for the prevention of infestations caused by New World screwworm (Cochliomyia hominivorax; NWS) larvae (myiasis) in sheep, cattle, goats, swine, camelids, and the following captive and captured wildlife species: cervids, American bison, bighorn sheep, and Sonoran pronghorn. FDA has issued one EUA for an animal product as requested by Zoetis Inc. for the treatment of infestations caused by NWS (myiasis) in dogs and puppies. FDA has issued one EUA for an animal product as requested by Bimeda Animal Health Ltd. for the prevention of infestations caused by NWS (myiasis) in cattle. FDA has issued one EUA for an animal product as requested by Sergeant's Pet Care Products LLC for the treatment and prevention of infestations caused by NWS (myiasis) in dogs, puppies, cats and kittens 2 pounds of body weight or greater and 4 weeks of age and older. The Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the August 18, 2025, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves NWS. On the basis of such determination, the Secretary of HHS declared on August 18, 2025, that circumstances exist justifying the authorization of emergency use of animal drugs to treat or prevent NWS myiasis in animals. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.

  • Takes effect 73 days ago

91 FR 65562FR Doc. 2026-21084official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentCenters for Disease Control and Prevention

Order Under Sections 362 and 365 of the Public Health Service Act Continuing the Suspension of the Right To Introduce Certain Persons From Countries Where a Quarantinable Communicable Disease Exists

The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Human Services (HHS), announces it is issuing an Order under Sections 362 and 365 of the Public Health Service Act, and associated implementing regulations, continuing the suspension of the right to introduce certain persons from countries where an outbreak of a quarantinable communicable disease exists. This Order was issued on October 11 and shall remain in effect through 4:59 p.m. Eastern Daylight Time (EDT) on Tuesday, November 10, 2026. This Order may be amended or rescinded prior to that time at the discretion of the Director.

  • Takes effect 8 days ago

91 FR 65556FR Doc. 2026-21036official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products Scientific Advisory Committee (TPSAC)

The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Tobacco Products Scientific Advisory Committee (TPSAC), in the Center for Tobacco Products. FDA seeks to include the views of qualified individuals on its advisory committees and therefore encourages nominations of appropriately qualified candidates. Specifically, TPSAC is seeking to fill 2 voting member vacancies with physicians, dentists, scientists, or health care professionals practicing in the areas of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, engineering, or any other relevant specialty.

91 FR 65592FR Doc. 2026-21027official PDFfederalregister.gov

14 October 2026 15 documents

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The Health and Human Services Department published 15 documents on October 14, 2026, comprising 13 notices, one proposed rule, and one final rule.

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NoticeHealth and Human Services DepartmentFood and Drug Administration

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Cosmetic Products

The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

  • Comments close in 25 days

91 FR 65219FR Doc. 2026-20990official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Advisory Committee; Cellular, Tissue, and Gene Therapies Advisory Committee; Renewal

The Food and Drug Administration (FDA) is announcing the renewal of the Cellular, Tissue, and Gene Therapies Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Cellular, Tissue, and Gene Therapies Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the October 28, 2028, expiration date.

91 FR 65223FR Doc. 2026-20989official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentIndian Health Service

Request for Public Comment: 60-Day Notice for Proposed Information Collection: Indian Health Service Purchased/Referred Care Proof of Residency

In compliance with the Paperwork Reduction Act (PRA) of 1995, which requires a 60-day public comment period on proposed information collection projects, the Indian Health Service (IHS) invites the public to take this opportunity to comment on the information collection titled, "Purchased/Referred Care (PRC) Proof of Residency" The purpose of this notice is to announce our intent to seek reinstatement of the previously approved information collection by the Office of Management and Budget (OMB), and to allow 60 days for public comment to be submitted to the IHS. A copy of the draft supporting statement is available at www.regulations.gov (see Docket ID IHS_FRDOC___).

  • Comments close in 56 days

91 FR 65229FR Doc. 2026-20984official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail Food Regulatory Program Standards

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

  • Comments close in 25 days

91 FR 65221FR Doc. 2026-20981official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Requirements

The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

  • Comments close in 25 days

91 FR 65225FR Doc. 2026-20980official PDFfederalregister.gov

RuleHealth and Human Services DepartmentFood and Drug Administration

Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate

The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium propionate as a source of chromium in food for laying hens and breeder chickens. This action is in response to a food additive petition filed by Kemin Industries, Inc.

  • Comments close in 25 days
  • Takes effect 5 days ago

91 FR 65109FR Doc. 2026-20979official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentHealth Resources and Services Administration

Health Center Program Performance Period Extensions; Correction

HRSA published a document in the Federal Register on September 24, 2026, concerning performance period extensions for health centers scheduled to compete for a January, February, or March FY 2027 Service Area Competition. The document did not include one service area that was not eligible for a performance period extension at the time of publication but has since become eligible.

91 FR 65228FR Doc. 2026-20960official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentCenters for Disease Control and Prevention

Proposed Data Collection Submitted for Public Comment and Recommendations

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Performance Monitoring of CDC's Comprehensive Suicide Prevention Program. This program seeks to reduce suicide morbidity and mortality by 10% in populations disproportionately impacted by suicide in participating jurisdictions.

  • Comments close in 56 days

91 FR 65217FR Doc. 2026-20919official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentNational Institutes of Health

Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director Notice of Proposed Reorganization

The Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) in the Office of the Director (OD), National Institutes of Health (NIH) is seeking public comment regarding its proposal to establish the Office of the NIH Chief Artificial Intelligence Officer (OCAIO) within DPCPSI and move the Office of Dietary Supplements (ODS) under the Office of Nutrition Research (ONR) within DPCPSI in OD, NIH.

  • Comments close in 9 days

91 FR 65229FR Doc. 2026-20891official PDFfederalregister.gov

13 October 2026 6 documents

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The Health and Human Services Department published six documents, including a final rule permitting salt substitutes in standardized foods effective December 14, 2026.

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NoticeHealth and Human Services DepartmentHealth Resources and Services Administration

Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Healthy Start Evaluation and Quality Improvement, OMB No. 0915-0338-Revision

In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.

  • Comments close in 24 days

91 FR 64933FR Doc. 2026-20867official PDFfederalregister.gov

RuleSIGNIFICANT · E.O. 12866Health and Human Services DepartmentFood and Drug Administration

Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods

The Food and Drug Administration (FDA or we) is issuing a final rule to amend our standard of identity regulations that specify salt (sodium chloride) as a required or optional ingredient to permit the use of salt substitutes in standardized foods, to reduce the sodium content. Reducing sodium may help reduce the risk of hypertension, a major risk factor for heart disease and stroke. The rule will help support a healthier food supply by providing flexibility to facilitate industry innovation in the production of standardized foods lower in sodium while maintaining the basic nature and essential characteristics of the foods.

  • Takes effect in 56 days

91 FR 65040FR Doc. 2026-20848official PDFfederalregister.gov

NoticeHealth and Human Services Department

Announcing Solicitation of Written Comments To Inform the Physical Activity Guidelines for Americans, 2nd Edition Supplement: 2027 Steps and Muscle-Strengthening Guidance

The Department of Health and Human Services (HHS) announces the solicitation of public comments to inform the development of the Physical Activity Guidelines for Americans, 2nd edition Supplement: 2027 Steps and Muscle-Strengthening Guidance (2027 Steps and Muscle- Strengthening Guidance).

  • Comments close in 24 days

91 FR 64935FR Doc. 2026-20833official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentNational Institutes of Health

2025-2026 IACC Summary of Advances

The Interagency Autism Coordinating Committee (IACC) is preparing its Summary of Advances, a statutorily mandated report that highlights the most consequential autism research of the past year. The Committee is seeking suggested research articles to highlight for this report. On behalf of the IACC, the National Institute of Mental Health (NIMH) Office of Autism Research Coordination (OARC) is collecting research article suggestions from members of the public.

  • Comments close in 4 days

91 FR 64935FR Doc. 2026-20825official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers." This guidance provides answers to commonly asked questions from applicants and other interested parties regarding postapproval manufacturing changes made to biosimilar and interchangeable biosimilar products licensed under the Public Health Service Act (PHS Act). This guidance finalizes the draft guidance of the same title issued on July 23, 2024.

91 FR 64931FR Doc. 2026-20817official PDFfederalregister.gov

9 October 2026 20 documents

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The Food and Drug Administration published 20 documents including three device classifications, notices of drug application withdrawals and approvals, and information collection requests.

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NoticeHealth and Human Services DepartmentFood and Drug Administration

Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ZANVASTRO (Zilganersen)

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that ZANVASTRO (zilganersen), approved September 3, 2026, manufactured by Ionis Pharmaceuticals, Inc., meets the criteria for a priority review voucher.

91 FR 64663FR Doc. 2026-20769official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biologics License Applications, Procedures and Requirements

The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

  • Comments close in 21 days

91 FR 64654FR Doc. 2026-20768official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Determination of Regulatory Review Period for Purposes of Patent Extension; MONOFERRIC

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MONOFERRIC and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

  • Comments close in 50 days

91 FR 64660FR Doc. 2026-20766official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expanded Access to Investigational Drugs for Treatment Use

The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

  • Comments close in 21 days

91 FR 64659FR Doc. 2026-20765official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Determination That LASIX (Furosemide) Oral Solution, 10 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA, Agency, or we) has determined that LASIX (furosemide) oral solution, 10 milligrams (mg)/ milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

91 FR 64662FR Doc. 2026-20764official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Par Health USA LLC, U.S. Agent for PH Health Limited, et al.; Withdrawal of Approval of 37 Abbreviated New Drug Applications

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 37 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

91 FR 64652FR Doc. 2026-20762official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Amneal Pharmaceuticals of New York, LLC; Withdrawal of Approval of Abbreviated New Drug Application for Celecoxib Capsules, 50 Milligrams, 100 Milligrams, 200 Milligrams, and 400 Milligrams

The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 208833 for Celecoxib capsules, 50 milligrams (mg), 100 mg, 200 mg, and 400 mg, held by Amneal Pharmaceuticals of New York, LLC, 50 Horseblock Rd., Brookhaven, NY 11719 (Amneal). Amneal requested withdrawal of approval of this application and has waived its opportunity for a hearing.

91 FR 64658FR Doc. 2026-20758official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentHealth Resources and Services Administration

Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Data System for Organ Procurement and Transplantation Network, OMB No. 0906-0110-Revision

In compliance with of the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.

  • Comments close in 21 days

91 FR 64665FR Doc. 2026-20732official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentHealth Resources and Services Administration

Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Applicant Organizational National Provider Identifiers and Centers for Medicare & Medicaid Services Certification Numbers Form

In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.

  • Comments close in 21 days

91 FR 64663FR Doc. 2026-20731official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on June 3, 2026. The document announced the withdrawal of approval of 16 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of July 6, 2026. The document indicated that FDA was withdrawing approval of ANDA 207366 for ribavirin solution, 6 grams/vial, held by Navinta LLC, 1499 Lower Ferry Rd., Ewing, NJ 08618; ANDA 212957 for fosaprepitant dimeglumine powder, Equivalent to (EQ) 150 milligrams (mg) base/vial, held by Navinta LLC; and ANDA 218638 for nicardipine hydrochloride (HCl) capsule, 20 mg and 30 mg, held by Navinta LLC. Before FDA withdrew the approval of these ANDAs, Navinta LLC informed FDA that they did not want the approval of the ANDAs withdrawn. Because Navinta LLC timely requested that approval of the ANDAs not be withdrawn, the approval is still in effect. This notice removes the entries for ANDA 207366, ANDA 212957, and ANDA 218638.

91 FR 64652FR Doc. 2026-20730official PDFfederalregister.gov

RuleHealth and Human Services DepartmentFood and Drug Administration

Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected Specimens

The Food and Drug Administration (FDA) is classifying the system for detection of nucleic acid from non-viral microorganism(s) causing sexually transmitted infections using home-collected specimens into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the system for detection of nucleic acid from non-viral microorganism(s) causing sexually transmitted infections using home-collected specimens. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

  • Takes effect 10 days ago

91 FR 64611FR Doc. 2026-20727official PDFfederalregister.gov

RuleHealth and Human Services DepartmentFood and Drug Administration

Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use

The Food and Drug Administration (FDA) is classifying the infant pulse rate and oxygen saturation monitor for over-the-counter use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the infant pulse rate and oxygen saturation monitor for over-the-counter use. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

  • Takes effect 10 days ago

91 FR 64615FR Doc. 2026-20726official PDFfederalregister.gov

RuleHealth and Human Services DepartmentFood and Drug Administration

Medical Devices; Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment Kit

The Food and Drug Administration (FDA) is classifying the hematopoietic cell enrichment kit into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the hematopoietic cell enrichment kit. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

  • Takes effect 10 days ago

91 FR 64609FR Doc. 2026-20725official PDFfederalregister.gov

Proposed RuleHealth and Human Services DepartmentFood and Drug Administration

Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry titled "Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants." The draft guidance states that, at this time and based on our current understanding of the risks, FDA does not intend to enforce certain regulatory requirements as they apply to certain entities and/or activities. The applicable requirements are established in our regulation titled "Requirements for Additional Traceability Records for Certain Foods."

  • Comments close in 35 days

91 FR 64629FR Doc. 2026-20721official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Challenges and Solutions in Lot-Level Food Traceability; Public Meeting

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting titled "Challenges and Solutions in Lot- Level Food Traceability." The purpose of the meeting is to provide a forum for the public to share information on continued implementation of the "Requirements for Additional Traceability Records for Certain Foods" final rule and areas of concern, especially as they relate to lot-level tracking, and identify potential flexibilities to support compliance.

  • Comments close in 48 days

91 FR 64656FR Doc. 2026-20720official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentNational Institutes of Health

Prospective Grant of Exclusive License, Inter-Institutional Agreement-Institution Lead: Antibody Specifically Binding to Severe Fever With Thrombocytopenia Syndrome Virus Antigen and Use Thereof

The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive, sublicensable patent license to Korea National Institute of Health, located in Cheongju-si, Chungcheongbuk-do, South Korea to practice the invention embodied in the patent application listed in the Supplementary Information section of this notice.

  • Comments close in 7 days

91 FR 64672FR Doc. 2026-20705official PDFfederalregister.gov

Earlier

43 further days of this agency's activity are in the long-form archive, oldest to newest, on one page.

Everything Health and Human Services Department has published, 2026-08-10 to 2026-10-16 →

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Using the Downstream MCP server at mcp.downstream.sh, call whats_new_since with agency "Health and Human Services Department" since 2026-10-09, then summarise what changed and list every deadline it created.

Reaches whats_new_since. The response carries its own citations and states what it is missing — including which dates it has no record for.